Improved Training Program for Fall Prevention of War Fighters

Limb Injury Clinical Trial

— RapidRehab  

Official title:

Improved Training Program for Fall Prevention of War Fighters With Lower Extremity Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446131
• Other study ID #: RRII
• Secondary ID: W81XWH-15-2-0071
• Status: Completed
• Start date: March 12, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will train War Fighters with lower extremity trauma to decrease fall risk.

Description:

Eligible active duty service members, retired or veterans who participated in rehabilitation programs at Department of Defense Advanced Rehabilitation Centers (Walter Reed National Military Medical Center, Center for the Intrepid-San Antonio Military Medical Center and/or the Naval Medical Center San Diego) will be considered for enrollment in this study. This study will look at service members who have undergone transfemoral, transtibial or bilateral lower extremity amputation or limb salvage procedures. Participants will receive fall prevention training on an instrumented treadmill (6, training sessions). Participants will receive three performance assessments:-immediately following completion of the treadmill training and at three and six months following the completion of the training. Post training, twice per month subjects will receive an email containing a follow up fall questionnaire monitoring if they have fallen and the circumstances surrounding their fall. If they do not have access to email, or if a timely response is not received from the email questionnaire which was sent out, subjects will be contacted by phone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Eligible active duty and retired service members and veterans with lower limb trauma

• Transfemoral amputation, transtibial amputation, bilateral amputation and or limb salvage

• Participated in conventional rehab at one of the following rehab centers: Walter Reed National Medical Center, Center for the Intrepid Brooke Army Medical Center, Naval Medical Center San Diego

• Community ambulator

• Prosthesis / Orthosis use daily

• Exclusion Criteria:

• Dysvascular disease

• Excessive pain

• Neuromuscular problems preventing the performance of study protocol

Related Conditions & MeSH terms

• Limb Injury

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Center for the Intrepid Brooke Army Medical Center	San Antonio	Texas
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
Mayo Clinic	Brooke Army Medical Center, United States Naval Medical Center, San Diego, University of Illinois at Chicago, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (27)

Armed Forces Health Surveillance Center (AFHSC). Medical evacuations from Operation Iraqi Freedom/Operation New Dawn, active and reserve components, U.S. Armed Forces, 2003-2011. MSMR. 2012 Feb;19(2):18-21. — View Citation

Bedigrew KM, Patzkowski JC, Wilken JM, Owens JG, Blanck RV, Stinner DJ, Kirk KL, Hsu JR; Skeletal Trauma Research Consortium (STReC). Can an integrated orthotic and rehabilitation program decrease pain and improve function after lower extremity trauma? Clin Orthop Relat Res. 2014 Oct;472(10):3017-25. doi: 10.1007/s11999-014-3609-7. — View Citation

Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation. Arch Phys Med Rehabil. 2007 Jan;88(1):109-14. — View Citation

Doukas WC, Hayda RA, Frisch HM, Andersen RC, Mazurek MT, Ficke JR, Keeling JJ, Pasquina PF, Wain HJ, Carlini AR, MacKenzie EJ. The Military Extremity Trauma Amputation/Limb Salvage (METALS) study: outcomes of amputation versus limb salvage following major lower-extremity trauma. J Bone Joint Surg Am. 2013 Jan 16;95(2):138-45. doi: 10.2106/JBJS.K.00734. — View Citation

Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil. 2004 May;85(5):743-8. — View Citation

Gooday HM, Hunter J. Preventing falls and stump injuries in lower limb amputees during inpatient rehabilitation: completion of the audit cycle. Clin Rehabil. 2004 Jun;18(4):379-90. — View Citation

Guillebastre B, Calmels P, Rougier P. Effects of rigid and dynamic ankle-foot orthoses on normal gait. Foot Ankle Int. 2009 Jan;30(1):51-6. doi: 10.3113/FAI.2009.0051. — View Citation

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Macefield VG. Physiological characteristics of low-threshold mechanoreceptors in joints, muscle and skin in human subjects. Clin Exp Pharmacol Physiol. 2005 Jan-Feb;32(1-2):135-44. Review. — View Citation

Miller WC, Deathe AB, Speechley M, Koval J. The influence of falling, fear of falling, and balance confidence on prosthetic mobility and social activity among individuals with a lower extremity amputation. Arch Phys Med Rehabil. 2001 Sep;82(9):1238-44. — View Citation

Miller WC, Speechley M, Deathe B. The prevalence and risk factors of falling and fear of falling among lower extremity amputees. Arch Phys Med Rehabil. 2001 Aug;82(8):1031-7. — View Citation

Owens JG, Blair JA, Patzkowski JC, Blanck RV, Hsu JR; Skeletal Trauma Research Consortium. Return to running and sports participation after limb salvage. J Trauma. 2011 Jul;71(1 Suppl):S120-4. doi: 10.1097/TA.0b013e3182219225. — View Citation

Owens JG. Physical therapy of the patient with foot and ankle injuries sustained in combat. Foot Ankle Clin. 2010 Mar;15(1):175-86. doi: 10.1016/j.fcl.2009.10.005. Review. — View Citation

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Patzkowski JC, Blanck RV, Owens JG, Wilken JM, Blair JA, Hsu JR. Can an ankle-foot orthosis change hearts and minds? J Surg Orthop Adv. 2011 Spring;20(1):8-18. — View Citation

Patzkowski JC, Blanck RV, Owens JG, Wilken JM, Kirk KL, Wenke JC, Hsu JR; Skeletal Trauma Research Consortium. Comparative effect of orthosis design on functional performance. J Bone Joint Surg Am. 2012 Mar 21;94(6):507-15. doi: 10.2106/JBJS.K.00254. — View Citation

Pauley T, Devlin M, Heslin K. Falls sustained during inpatient rehabilitation after lower limb amputation: prevalence and predictors. Am J Phys Med Rehabil. 2006 Jun;85(6):521-32; quiz, 533-5. — View Citation

Ramstrand N and Ramstrand S. (2010). The effect of ankle-foot orthoses on balance - Asystematic Review. Journal of Prosthetics and Orthotics; 22(4S): p4-p23.

Shumway-Cook A, Woollacott MH. (1995). Motor learning and recovery of function. InMotor Control: Theory and Practical Application (pp. 23-443). Baltimore, MD:Williams & Wilkens.

van Velzen JM, van Bennekom CA, Polomski W, Slootman JR, van der Woude LH, Houdijk H. Physical capacity and walking ability after lower limb amputation: a systematic review. Clin Rehabil. 2006 Nov;20(11):999-1016. Review. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Trunk Position	Trunk Position (referenced to vertical) at recovery step completion	Change from baseline at 0, 3, and 6 months after completing training
Primary	Change in Trunk Velocity	Trunk Velocity at recovery step completion	Change from baseline at 0, 3, and 6 months after completing training
Secondary	Falls	Falls per month reported in the Prosthesis Evaluation Questionnaire - Addendum	Change from baseline at 0, 3, and 6 months after completing training
Secondary	FSST	Four-Square Step Test	Change from baseline at 0, 3, and 6 months after completing training

External Links

•   Mayo Clinic Clinical Trials